21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

Start Date : June 19, 2018
End Date : June 20, 2018
Time : 8:30 am to5:00 pm

Phone : 800-447-9407
Email : globalcompliancepanel@gmail.com

Location :
Mandarin Orchard Singapore 333 Orchard Road, Singapore

Website

Description

Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:





Course Objectives:





Who will benefit:



Agenda:


Day 1 Schedule




Lecture 1:


Introduction to the FDA





Lecture 2:


21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures





Lecture 3:


The Five Keys to COTS Computer System Validation



Day 2 Schedule




Lecture 1:


Ten-Step Process for COTS Risk-Based Computer System Validation





Lecture 2:


How to Write Requirements and Specifications





Lecture 3:


How to Conduct a Hazard Analysis/Risk Assessment-Exercise





Lecture 4:


Software Testing





Lecture 5:


System Change Control





Lecture 6:


Purchasing COTS Software





Lecture 7:


Cost Reduction Without Increasing Regulatory or Business Risk



Speaker


David Nettleton


FDA Compliance Specialist,


Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.


 


Location:  Singapore Date: June 19th & 20th, 2018 and Time: 8:30 AM to 5:00 PM


Venue:  Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867


 


Price:


Price: $1,695.00 (Seminar Fee for One Delegate)


 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*


Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


Register now and save $200. (Early Bird)


Until May 10, Early Bird Price: $1,295.00 From May 11 to June 17, Regular Price: $1,495.00


Sponsorship Program benefits for “Biostatistics for Non-Statistician” seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901765SEMINAR?SEO


 


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901765SEMINAR?meetings4docs_june_2018_seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane,suite 216

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

Tel: 8004479407
Mobile: 8004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com


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